Biosimilars represent one of the pillars of Actavis’ strategy to drive long-term growth and the Company is committed to building a leadership position in the emerging global biosimilars market. We believe that biosimilars are the next frontier in the evolution of healthcare.
Actavis Specialty Brands’ biosimilar product pipeline currently consists of five products in various stages of development: one product for the treatment of female infertility being developed internally and the four oncology products being developed within the Amgen/Actavis Collaboration.
This strategy, which is supported by our biosimilars team, formally known as Eden Biodesign, was expanded in December 2011 when we announced a collaboration with Amgen to develop and commercialize, on a worldwide basis, biosimilar versions of Herceptin®, Avastin®, Rituxan/Mab Thera®, and Erbitux®.
These products represent some of the fastest-growing pharmaceutical products in the world with peak innovator sales topping $20 billion, and we expect the collaboration to launch its first biosimilar products beginning in 2017.
In July 2012, Actavis entered into a global license agreement with Synthon, obtaining an exclusive license to its biosimilar version of Herceptin®, an FDA approved treatment for breast and gastric cancers. Actavis subsequently contributed the product to the Amgen/Actavis collaboration.
This collaboration places Amgen and Actavis in an unparalleled position in the global biosimilars market by capitalizing on best-in-class capabilities in both innovative biologics and specialty pharmaceuticals and generics. It delivers on Actavis’ promise to be a leader in the field of biosimilars, and does so in a way that helps manage the substantial financial investment, operational capabilities and broad commercial skills required to bring safe, high-quality and cost-effective biosimilar therapies to patients.
The Amgen/Actavis collaboration is in addition to Actavis’ ongoing efforts to develop and commercialize Itero Biopharmaceuticals, Inc.’s recombinant follicle stimulating hormone (rFSH) productas a biosimilar molecule for the treatment of female infertility. This program is currently in Phase I, and we expect it to progress to Phase III in 2013.